The U.S. Food and Drug Administration has granted full approval to KBroVet (potassium bromide chewable tablets) for the control of seizures in dogs with idiopathic epilepsy. The product is indicated for daily oral administration and is available by prescription, reflecting the need for veterinary diagnosis and ongoing monitoring. The chewable tablet is available only by prescription to reduce the risk of bromide intoxication, which can occur when high levels of bromide overwhelm the nervous system. Reported signs may include depression, behavioral changes, ataxia, weakness, hind limb paresis, mydriasis, stupor, and coma. Veterinarians are also advised to counsel clients on avoiding abrupt dietary changes, which can affect bromide levels and seizure control. KBroVet received conditional FDA approval in January 2021 under the agency’s expanded conditional approval pathway, which applies to drugs addressing serious or unmet medical needs. After four annual renewals, manufacturer Pegasus Laboratories reportedly generated sufficient effectiveness data to support full approval.
